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Shire Reports Positive Signal Finding Study of Investigative Use of Vyvanse(R) (lisdexamfetamine dimesylate) Capsules as Adjunctive Treatment in Major Depressive Disorder
Date:10/29/2010

ligible subjects received escitalopram plus either placebo or Vyvanse (dose optimized over the range of 20 to 50 mg per day) on a 1:1 basis.

The primary study endpoint was the mean change in the total MADRS score after 6 weeks of blinded treatment in the non-remitter subset (n=129) of the randomized population, defined as subjects with a total MADRS score of >10 after the 8 week escitalopram treatment. The significance level was prospectively set at 10%.

Vyvanse demonstrated improvement compared to placebo on the mean total MADRS of -2.3 [90% CI -4.5 to -0.1] after 6 weeks of treatment in the primary analysis of non-remitting subjects (p=0.090). An additional pre-planned analysis was conducted among subjects who had a total MADRS score >10 and achieved < 50% improvement in total MADRS score (n=86). This analysis found an endpoint LS mean difference between Vyvanse and placebo of -3.9 [90% CI -6.5 to -1.3; p=0.0132 (not adjusted for multiplicity)]. The most commonly reported adverse events (dry mouth, headache, decreased appetite, and insomnia) in the trial were consistent with the known, labeled profile of VYVANSE in ADHD. Mean blood pressure and mean heart rate changes were also consistent with the product label. No notable mean ECG changes or mean changes in clinical laboratory assessments were reported in this study. The mean dose per day of VYVANSE used for adjunctive therapy with escitalopram was 29.6 mg.

"Only about 30 to 33 percent of patients will achieve full symptom remission with the first step standard antidepressant treatment," said Madhukar H. Trivedi, Professor of Psychiatry at University of Texas Southwestern Medical School. "Therefore, almost two-thirds of patients starting an antidepressant will need a second or third step treatment to achieve symptom relief. We are encouraged by the signal findings we've seen in this Phase 2 study and look forward to further evaluating Vyvanse for adjunctive treatment of patients w
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SOURCE Shire plc
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